Job Details
Job Title: Principal Scientist, Clinical Biomarker
Company Overview: Join a dynamic and forward-thinking mid-sized biotech company dedicated to advancing breakthrough therapies and diagnostics in the field of life sciences. Our client's innovative research and collaborative approach drive meaningful progress in healthcare, with a focus on improving patient outcomes and addressing unmet medical needs.
Position Overview: We are seeking an accomplished and visionary Principal Scientist specializing in Clinical Biomarker research to lead and shape our client's biomarker strategy. The successful candidate will be instrumental in driving biomarker discovery, validation, and implementation across clinical development programs, contributing to the success of the company's pipeline and ultimately improving patient care.
Responsibilities:
Biomarker Strategy Development:
- Lead the development of biomarker strategies aligned with clinical development objectives and therapeutic indications.
- Define biomarker endpoints and establish biomarker-driven patient selection criteria in collaboration with cross-functional teams.
- Drive innovative approaches to identify, validate, and integrate biomarkers into clinical trials to enhance decision-making and patient stratification.
Clinical Biomarker Discovery and Validation:
- Oversee the design, execution, and interpretation of biomarker studies, leveraging cutting-edge technologies and methodologies.
- Collaborate closely with translational medicine, bioinformatics, and external partners to identify and validate novel clinical biomarkers predictive of treatment response, disease progression, and safety.
- Ensure robustness, reproducibility, and regulatory compliance of biomarker assays and data generated across clinical studies.
Clinical Trial Support:
- Provide strategic and scientific guidance on biomarker implementation and data analysis for ongoing and upcoming clinical trials.
- Contribute to clinical study protocols, informed consent documents, and regulatory submissions to support biomarker-driven trial designs.
- Participate in data review meetings, safety monitoring, and interpretation of biomarker results to inform clinical development decisions.
Cross-Functional Collaboration:
- Collaborate closely with clinical development, translational medicine, biostatistics, regulatory affairs, and external collaborators to integrate biomarker strategies into clinical programs.
- Communicate biomarker findings and implications effectively to diverse stakeholders, including project teams, senior management, regulatory agencies, and external partners.
- Foster a collaborative and inclusive work environment that encourages knowledge sharing, scientific rigor, and continuous learning.
Qualifications:
- Ph.D. or equivalent degree in Molecular Biology, Biochemistry, Pharmacology, or related field with a minimum of 8 years of relevant experience in clinical biomarker research within the biopharmaceutical industry.
- Demonstrated expertise in developing and validating clinical biomarkers across various therapeutic areas, with a track record of successful implementation in clinical trials.
- Strong knowledge of biomarker technologies and methodologies, including genomics, proteomics, imaging, and flow cytometry, as applied to clinical research.
- Experience with biomarker assay development, validation, and regulatory submissions (e.g., FDA, EMA) in compliance with industry standards and guidelines.
- Proven leadership skills with the ability to drive cross-functional initiatives, mentor team members, and influence decision-making at all levels of the organization.
- Excellent communication and presentation skills, with the ability to distill complex scientific concepts into clear and compelling messages for diverse audiences.
- Strategic mindset with a passion for innovation, problem-solving, and driving scientific excellence in a dynamic and collaborative environment.